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Biosimilars and Biobetters 2018
26 September - 27 September 2018
Biosimilars and Biobetters 2018

SAE Media Group’s 9th Annual Conference
Biosimilars and Biobetters
September 26th-27th, 2018 | London, United Kingdom
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Following the success of our previous events in both UK and USA, Biosimilars and Biobetters UK 2018 will deliver a stellar speaker line-up and bring together a global audience of biosimilar experts to discuss the latest developments and future of the rapidly evolving and expanding biosimilars market.

After over a decade, the biosimilars industry is finally reaching a stage where key stakeholders understand and accept biosimilars. This is reflected in more tolerant legislation and an increased uptake of biosimilars across the globe.

We are now entering a very exciting time, for over the next few years several originator patents are expiring, and we will see a new wave of biosimilars enter the market. Will the originator dominate or will the biosimilar be a successful contender and spark a competitive environment? Have we done enough to convince the payer, prescriber and patient to switch?

FEATURED SPEAKERS

Aurelio Arias

Aurelio Arias

Senior Thought Leadership Consultant, Iqvia
Michael Muenzberg

Michael Muenzberg

Member of the Comparative Outcomes Group , Former Medical Director Biosimilars EU, Amgen
Michel  Mikhail

Michel Mikhail

International Expert in Regulatory Affairs, Global Expert in Biosimilars
Niklas Czeloth

Niklas Czeloth

Head of Biosciences Biosimilars, Boehringer Ingelheim GmbH
Omar Ali

Omar Ali

Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth
Paul Harmon

Paul Harmon

Senior Director, European Oncology Biologics Lead, Mylan Technologies Inc
Uwe Gudat

Uwe Gudat

Head of Clinical Safety & Pharmacovigilance, Fresenius-Kabi

Aurelio Arias

Senior Thought Leadership Consultant, Iqvia
Aurelio Arias

Aurelio is a Senior Consultant in the Thought Leadership team at IQVIA, a market leader in healthcare data, real world evidence, clinical trials and consulting.

Aurelio generates thought leadership insights with a view to spark high-level discourse on current and future pharma trends. He presents at numerous conferences worldwide and advises executives on global pharma strategy. His primary focus lies within the off-patent markets.

Prior to IQVIA, Aurelio has advised blue chip companies in both Life Sciences and Financial Services while working for LEK and Accenture. He has worked in R&D for Pfizer and GlaxoSmithKline while completing a Chemistry degree at Imperial College London.

Christian Naumann

Head Global Marketing Biopharmaceuticals, Sandoz International GmBH
Christian Naumann

Christian Naumann is the Head Global Marketing Biopharmaceuticals for Sandoz International. He has more than 20 years of experience in international pharmaceutical corporations across corporate, regional and general management positions, leading successful teams in Europe, Japan and Latin America and holding global commercial and marketing roles for Bayer Pharmaceuticals, Walgreens Boots Alliance and Sandoz. He has been with Sandoz in his current role since July 2016. Born in Argentina, Christian holds an engineering and business administration degree from Technische Universität Berlin in Germany.

Fraser Cummings

Consultant Gastroenterologist and Hon. Associate Professor, University Hospital Southampton NHS Foundation Trust
Fraser  Cummings

Dr Fraser Cummings is a consultant gastroenterologist at University Hospital Southampton (UHS) and Honorary Associate Professor at the University of Southampton Faculty of Medicine. At UHS he is clinical lead for the adult IBD service and delivers both basic science and clinical research programs with a focus on biologics and biosimilars. He is a member of the UK IBD program, NHS England biosimilars program board, clinical lead for the UK IBD registry.

John Chen

Senior Director of Corporate Development , Livzion Mabpharm Inc
John Chen

John was the Chief Investment Officer of Ming Gao Meditech Ltd., Co., a medical device
manufacturer specializing in safety syringes and other specialty delivery platforms. Prior to
joining Ming Gao, John was the Chief Financial Officer of ZST Digital Networks, Inc., a
previously NASDAQ listed company where he was responsible for the Company’s $25 million USD NASDAQ IPO and as a VP of Investment Banking at Brean Murray Carret, where he successfully completed a number of China-based PIPE deal valued over $75MM USD while overseeing its China-based practices.

Lorraine Fincham

Commercial Research Initiative Manager, NIHR Clinical Research Network
Lorraine Fincham

Lorraine is the Commercial Research Initiative Manager for the NIHR Clinical Research Network (CRN). Lorraine has worked actively as an academic researcher for several London Universities, working on prostate and bowel cancer studies after finishing her degree in Psychology and MSc in Health Psychology. She moved to the NIHR Clinical Research Network in 2007, firstly working locally in the North West London Diabetes Research Network as a Primary Care specialist before moving to the NIHR CRN Coordinating Centre in 2010. In her current role she works solely in the realm of commercial research and liaises with Pharmaceutical, Medtech and Biotech companies on a regular basis to improve collaborative relationships with the NIHR to deliver studies in the UK. She represents and attends the NIHR at national meetings with the Life Science industry. Her role also encompasses service improvements including the Biosimilar initiative. She liaises with the fifteen Industry Operations Managers within the Local Clinical Research Networks across England and with the Devolved Administrations for a UK wide service.

Meenu Wadhwa

Head, Cytokines & Growth Factors, Biotherapeutics Group, , National Institute for Biological Standards and Control
Meenu Wadhwa

Michael Muenzberg

Member of the Comparative Outcomes Group , Former Medical Director Biosimilars EU, Amgen
Michael Muenzberg

Dr. Mike Muenzberg received his M.D. degree from the Medical University of Vienna. He did his clinical training in Austria, Canada, South Africa and Sweden and is licensed in Nuclear Medicine. He is working since 20 years in Pharma Industry with Biotech Compounds, since 14 years as Global Medical Executive Biosimilars for SANDOZ, Merck Serono and Amgen.
Mike Muenzberg is currently working as an independent Consultant for Biosimilars and Biotech related topics and is member of the Comparative Outcomes Group.

Michel Mikhail

International Expert in Regulatory Affairs, Global Expert in Biosimilars
Michel  Mikhail

Dr. Michel Mikhail has more than 25 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical Companies, Biotech Companies as well as in the Generic industry. Dr Mikhail is an Expert in Biosimilars. Has been involved in the Global Development and Worldwide regulatory approval of Blockbuster Monoclonal antibodies Medicines. He was involved in shaping the EU Biosimilars Guidelines and their Review, the WHO Guidelines, ICH Guidelines and now in the US-FDA Biosimilars Guidelines. He is a Chartered Expert in Pharmacology-Toxicology, a chartered Clinical Expert as well as a chartered Analytical Expert. Dr Mikhail served on the Safety working group and Efficacy working Group of the European Federation of pharmaceutical Industry associations (EFPIA) also as a Topic leader. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America (PhRMA Europe), on the European Biosimilars Group, the Regulatory and Scientific Affairs Group of the European Generic medicines Association (EGA), as well as on different associations and organizations. Dr. Mikhail is member of the Expert committee of the Government Federal Institute of Risk Assessment (BfR) Germany and served as member of the Expert Committee for Toxicology of the United States Pharmacopoeia (USP).

Niklas Czeloth

Head of Biosciences Biosimilars, Boehringer Ingelheim GmbH
Niklas Czeloth

Niklas Czeloth has studied Biochemistry in Hannover (Germany) and specialized in Immunology during his PhD and Post-Doc time. He started his industrial career at Biotest AG as a Manager Toxicology and became Associate Director Pharmacology in the Non-clinical department at Biotest. After 5 years developing monoclonal antibodies at Biotest he joined Boehringer Ingelheim (Germany) as a Project Manager DMPK and became responsible for the PK and Immunogenicity activities for Biosimilars in the Biosciences group. Since June 2014, Niklas is heading the Biosciences group and is leading DMPK, Pharmacology and Toxicology activities for the biosimilar portfolio at Boehringer Ingelheim.

Omar Ali

Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth
Omar Ali

Qualified with a hospital pharmacy background, Omar has been working as the Formulary Advisor
for Surrey & Sussex Healthcare NHS Trust for over 15 years, sitting on the regional Joint Drugs &
Therapeutics Committee as well as the CCG/Commissioning Prescribing Clinical Network.
Omar has been a visiting Lecturer at UCLH Pharmacy Programme and was both Lecturer &
Examiner on the Independent Prescribing V300 Course at the University of Surrey and has over 30
publications to date. He has been appointed as Visiting Lecturer on Value Based Pricing & Innovative
Contracting at the University of Portsmouth, is an Editorial Content Adviser to Guidelines, and has
recently been invited to the position of Associate Editor to the Canadian Journal of Population
Therapeutics & Clinical Pharmacology.
Omar has served a position on the External Reference Group on Cost Impact Modelling for NICE for
6 years and was subsequently appointed Panel Member for the newly formed Adoption & Impact
Program Reference for NICE. He advises foreign investors (US Embassy) on ‘Value Based
Assessments (hosted by the UK Department of Trade & Industry) and recently delivered a Healthcare
NHS Reform program to over 40 Healthcare Insurance Provider delegates visiting from the US.
Last year he was invited to address the Italian Healthcare Senate [Senato della Repubblica] on
Pharmaco-economic Evaluation & Sustainability Models of Healthcare and featured at the
Westminster Health Forum Keynote Seminars [chaired by Lord Howe, All Party Parliamentary
Group on Pharmacy] on the Future for Pharmacy Commissioning, Organisation & Delivery. At this
current time he has embarked on a PhD with his doctorate thesis entitled “Value Based Pricing &
Outcomes Based, Innovative Contracting of New Medicines”.

Paul Harmon

Senior Director, European Oncology Biologics Lead, Mylan Technologies Inc
Paul Harmon

Paul has over 25 years’ experience across healthcare delivery and the pharmaceutical industry. He was worked across many therapy areas such as psychiatry, cardiology but with a predominant focus in Oncology. He has worked in the Irish healthcare service and after moving into the Pharma sector, worked across Europe with Warner Lambert, Pfizer, Cephalon, Teva and now Mylan. He has been responsible for the launch and management of numerous medicines with experience in originator solid oral dose, biologics, generics and biosimilars. Most recently Paul has worked in Pan European senior management roles which he has added to with his MBA and MSc in Leadership.

Richard Peck

Vice President Regulatory Affairs, Lupin (Europe) Ltd
Richard  Peck

Richard Peck studied medicine in the USA and obtained a Doctor of Philosophy from the University of Tennessee. Following a Post-Doc at the Biozentrum of the University of Basel (medical virology, molecular biology), he was employed by F. Hoffmann La Roche, Basel as International Regulatory Affairs Manager (Global Regulatory Leader). He holds a Master of Science in Regulatory Affairs at the University of Wales in Cardiff. He was appointed as Head of Regulatory Affairs at CSL-Behring and became Director of Regulatory Affairs at Finox. He is now Vice President Regulatory Affairs at Lupin Ltd in Zug, Switzerland, a company specialising in the development of biosimilar medicines.

Rod Ball

Owner and Director, Impact Medical Education
Rod Ball

Roderick Ball is Director of the specialist biosimilar consultancy, Impact. Impact designs and delivers programmes to help accelerate biosimilar adoption and support their long-term sustainability. Over the past 3 years, Impact has supported the most successful global biosimilar launch to date. Rod began his career at GSK as a graduate marketeer and has over 20 years’ experience in medical education.

 

Rodeina Challand

General Manager, Challand Biosimilar Consulting
Rodeina Challand

Science and Law Graduate with 30 years of experience in healthcare, cancer research, pharmaceutical industry and CRO, across a wide range of roles including developing and implementing clinical development strategies for biosimilars and complex generics. Experience in all aspects of biosimilar development including study design and regulatory agency discussions (EMA, FDA, MENA, GCC, Australia, India, Japan and S. Korea). In the last few years have worked with the developing regions and conducted several meetings with MENA and GCC Regulatory Agencies to educate and better understand their expectations licensing biosimilars; also supporting them in implementing clinical trial regulations and educating potential investigators in the region. Worked on over 15 biosimilar molecules across a range of products and indications, including ESAs, Filgrastims, Heparins, Insulins and monoclonal antibodies in various capacity including consulting, regulatory and clinical strategies, feasibility and supporting study delivery across all phase of development (phase I to IV).

Ruchi Gupta

Senior Scientist, MedImmune
Ruchi Gupta

Dr. Ruchi Gupta earned her PhD from Stony Brook University and did her postdoctoral studies at Rockefeller University. Currently, she is a Sr. Scientist at MedImmune leading 2 separate groups: One group focuses on immuno-cardiology therapeutics for patients with heart disease and failure and second group is dedicated to finding technologies for tissue specific delivery. Ruchi has been the recipient of several awards including the Global excellence award, the entrepreneur of the year and innovation to invent.

Ruediger Jankowsky

Managing Director, Cinfa Biotech
Ruediger Jankowsky

Ruediger Jankowsky, PhD, Managing Director of Cinfa Biotech (Pamplona, Spain/ Munich, Germany)

Ruediger Jankowsky is responsible for the operational leadership of Cinfa Biotech, the biosimilars company of Cinfa Group, a pharmaceutical leader in Spain. He joined Cinfa Biotech in 2014 and has since then created corporate structures for the development, manufacturing and commercialisation of Cinfa Biotech’s products, and positioned the company in the market for high-quality biosimilars. Ruediger has nearly 20 years of experience in the pharmaceutical industry where he held various international executive positions in global and mid-size pharmaceutical companies.

Uwe Gudat

Head of Clinical Safety & Pharmacovigilance, Fresenius-Kabi
Uwe Gudat

Dr. med. Uwe Gudat received his medical degree from the Philipps-University of Marburg, Germany. He is licensed in internal medicine specializing in metabolic disorders, training under Michael Berger in Düsseldorf Germany. Uwe Gudat joined the pharmaceutical industry in 1995 with Eli Lilly and since then has held positions at Hesperion/Actelion, Novartis and Merck Serono. He has led global clinical development teams, served as global medical brand director, led global clinical due diligence teams for in-licensing, guided oversight over clinical trial designs, product safety assessments and first in man transitions. Previously Head of Safety, Biosimilars at Merck KGaA, he now leads Clinical Safety & Pharmacovigilance at Fresenius-Kabi SwissBioSim after the acquisition.

Warren Cook

Senior Commercial Lead - Biosimilars, Mundipharma International
Warren Cook

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Workshop leader introduction

Michel  Mikhail

Michel Mikhail, , Global Expert in Biosimilars

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9:10

Analytical similarity form the basis of the CMC dossier

Michel  Mikhail

Michel Mikhail, , Global Expert in Biosimilars

  • Choice of reference product
  • Batch to batch variability of the reference product
  • Representative biosimilar batch to be used in the clinical development
     
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    9:50

    Non-clinical development and clinical development of biosimilars

    Michel  Mikhail

    Michel Mikhail, , Global Expert in Biosimilars

  • The 3R concept: Replacement, reduction and refinement
  • In-vitro pre-clinical similarities vs. in-vivo animal studies
  • Phase 1 and phase 3 clinical development
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    10:40

    Morning Coffee and Networking Break

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    11:10

    EU vs. US regulatory requirements

    Michel  Mikhail

    Michel Mikhail, , Global Expert in Biosimilars

  • Using US reference product for the global EU and US development of biosimilars
  • Bridging studies vs. EU reference product
  • Cost of reference product vs. availability, blinding aspects
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    11:50

    Two-step approval in the US

    Michel  Mikhail

    Michel Mikhail, , Global Expert in Biosimilars

  • First step as a biosimilar
  • Second step as an interchangeable biosimilar
  • An introduction to the FDA interchangeability guidelines
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    12:30

    Close of workshop

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    13:30

    Registration & Coffee

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    14:00

    Workshop leader introduction

    Omar Ali

    Omar Ali, Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth

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    14:10

    Case examples of value-based agreements

    Omar Ali

    Omar Ali, Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth

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    14:40

    Analysis of market access and payer

    Omar Ali

    Omar Ali, Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth

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    15:10

    Afternoon Tea and Networking Break

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    15:40

    Construction of value-based agreements

    Omar Ali

    Omar Ali, Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth

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    16:10

    “How ugly is my child?“ – assessing value & innovation

    Omar Ali

    Omar Ali, Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth

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    16:30

    VBA Levers in construction of risk sharing

    Omar Ali

    Omar Ali, Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth

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    16:50

    Assessing and evaluating payer archetypes for VBA

    Omar Ali

    Omar Ali, Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth

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    17:10

    Internal VBA readiness and deployment of VBA

    Omar Ali

    Omar Ali, Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth

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    17:30

    Closing Remarks and Close of Workshop

    Omar Ali

    Omar Ali, Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars

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    9:10

    OPENING ADDRESS: After more than a decade of biosimilars in Europe – how will the markets change over the next couple of years?

    Michael Muenzberg, Member of the Comparative Outcomes Group , Former Medical Director Biosimilars EU, Amgen

    • Historical Background about Biosimilars from 2006 until now
    • Claims and Assumptions during the first years
    • Differences in the acceptance of Biosimilars between US and Europe – how come?
    • Biosimilars of Avastin®, Herceptin® and Humira® will enter the European markets in 2018/2019 – what can we expect?

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    9:50

    KEYNOTE ADDRESS: Sustainability, affordability and expanded patient access: The keys to ensuring biosimilar success in europe

    Paul Harmon, Senior Director, European Oncology Biologics Lead, Mylan Technologies Inc

    • Success for biosimilars involves delivering a positive impact today, but also continuously over time
    • Policy changes and widespread adoption will be critical to expand access and get these products in the hands of patients
    • Biosimilars must be viewed through a lens that goes beyond price, and includes overall affordability and sustained value

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    10:30

    Morning Coffee

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    11:00

    Succeeding with biosimilars: known knowns, known unknowns

    • Comparing and contrasting views of a clinical expert and commercial expert
    • Exploring lessons learned
    • Answers we are still pursuing

    Rod Ball, Owner and Director, Impact Medical Education

    Michael Muenzberg, Member of the Comparative Outcomes Group , Former Medical Director Biosimilars EU, Amgen

    Fraser Cummings, Consultant Gastroenterologist and Hon. Associate Professor, University Hospital Southampton NHS Foundation Trust

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    11:40

    Things to know about biosimilars today

    Christian Naumann, Head Global Marketing Biopharmaceuticals, Sandoz International GmBH

  • How has the worldwide market developed?
  • Are savings tangible for healthcare systems?
  • What drives pricing and sustainability of the market?
  • What determines your competitiveness? How to get ready for the future?
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    12:20

    Networking Lunch

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    13:20

    Engineering novel biobetters using targeted delivery technology

    Warren Cook

    Warren Cook, Senior Commercial Lead, Biosimilars, Mundipharma International

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    14:00

    CASE STUDY: Challenges in coming to market with an Etanercept biosimilar

    Richard Peck , Vice President Regulatory Affairs, Lupin (Europe) Ltd

    • Changes in the competitive environment
    • Biosimilar market trends
    • Uptake of biosimilars in different European countries
    • Regulatory requirements in different countries impact biosimilar uptake
    • Go-to-market considerations

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    14:40

    CASE STUDY: Biosimilar development in a mid-size pharma environment – the Pegfilgrastim case at Cinfa Biotech

    Ruediger Jankowsky, Managing Director, Cinfa Biotech

    • Case study example of pegfilgrastim biosimilar clinical trial design
    • Understanding how we can build a bridge between the originator and biosimilar product using a specific, consistent and tailor-made approach
    • The importance of study population, study design, endpoints and statistics
    • Collaborating with regulatory affairs and making clinical studies as sensitive to differences as possible

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    15:20

    Afternoon Tea

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    15:50

    Payer perspectives on value drivers for biosimilars

    Omar Ali, Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth

    • Healthcare Fiscal overview and medicines funding landscape for Biosimilars
    • New NHS CQUINs on Biosimilars and how payers are implementing this
    • How Payers are aligning biosimilars with innovative parent brands to streamline patient care settings
    • Physician loyalty [brand v biosimilar and biosimilar v biosimilar] and how this affects formulary uptake
    • What value offerings from biosimilars resonate with payers and formulary decison makers
    • Drivers for outcomes based, innovative contracting for new medicines
    • Bridging the 'uncertainty gap' between payers & pharma - the shifting paradigm

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    16:30

    Increasing market opportunities in China

  • Current competitive landscape of biosimilars and biobetters in China
  • Review the latest regulatory updates in China
  • Short-introduction of Livzon Mabpharm
  • John Chen, Senior Director of Corporate Development , Livzion Mabpharm Inc

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    17:10

    Chairman’s Closing Remarks and Close of Day One

    Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars

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    9:10

    Towards sustainability and harmonisation of biosimilars through WHO international standards

    Meenu Wadhwa

    Meenu Wadhwa, Head, Cytokines & Growth Factors, Biotherapeutics Group, , National Institute for Biological Standards and Control

    • The concept of international standardisation
    • Setting new standards: WHO international standards for monoclonal antibodies 
    • Future plans for WHO standards for biosimilars and immunogenicity testing

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    9:50

    US-FDA Interchangeability Guidance - what is needed to obtain the interchangeable status for the biosimilar product

    Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars

    • Learn the latest FDA regulatory changes towards interchangeability of biosimilars
    • Evaluation of biosimilars in the race to obtaining this status
    • First in line: recommendations on how to achieve interchangeability
    • Discuss what will need to be done after accomplishing this to increase biosimilar uptake in patients, physicians and prescribers’ groups

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    10:30

    Morning Coffee

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    11:00

    Do we really need clinical trials for a biosimilar?

    Uwe Gudat, Head of Clinical Safety & Pharmacovigilance, Fresenius-Kabi

    • What is the medico-scientific question?
    • Revisiting David Sackett (EBM)
    • Different stakeholders hold different perspectives
    • Is there an ethical dilemma?
    • Disagreeing agreeably

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    11:40

    Biosimilar orphan drugs

    Rodeina Challand, General Manager, Challand Biosimilar Consulting

    • The value of Orphan drugs
    • Why we need biosimilar orphan drugs
    • How do we show similarity?
    • What will the regulators expect?

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    12:20

    Networking Lunch

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    13:20

    Lessons from the front line; launching biosimilars in Europe

    Ruchi Gupta, Senior Scientist, MedImmune

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    14:00

    The importance of analytical and pharmacological data for the biosimilar development

    Niklas Czeloth, Head of Biosciences Biosimilars, Boehringer Ingelheim GmbH

    • Timing of method availability during the biosimilar development program
    • Tiering of quality attributes and the respective needs for analytics
    • Requirements for analytical and pharmacological methodologies to comply with regulatory expectations
    • The importance of structure function relationship knowledge

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    14:40

    Afternoon Tea

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    15:10

    Optimising biosimilar uptake

    Aurelio Arias, Senior Thought Leadership Consultant, Iqvia

    • With several biosimilars in the market, what lessons can we learn on subsequent launches?
    • Which countries provide a good environment for a biosimilar launch?
    • What levers does a manufacturer have to promote successful uptake?
    • What should be considered in creating an ideal commercial model?

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    15:50

    Experiences of delivering biosimilar medicine studies in a national health service

    Lorraine Fincham, Commercial Research Initiative Manager, NIHR Clinical Research Network

    • Case study examples of initiating biosimilar medicine trials in the NHS
    • Implementing solutions to unique challenges
    • Adopting the network approach to site selection
    • Increasing clinical confidence through education

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    16:30

    Chairman’s Closing Remarks and Close of Day Two

    Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars


    Senior Thought Leadership Consultant
    Iqvia
    Head Global Marketing Biopharmaceuticals
    Sandoz International GmBH
    Consultant Gastroenterologist and Hon. Associate Professor
    University Hospital Southampton NHS Foundation Trust
    Senior Director of Corporate Development
    Livzion Mabpharm Inc
    Commercial Research Initiative Manager
    NIHR Clinical Research Network
    Head, Cytokines & Growth Factors, Biotherapeutics Group,
    National Institute for Biological Standards and Control
    Member of the Comparative Outcomes Group
    Former Medical Director Biosimilars EU, Amgen
    International Expert in Regulatory Affairs
    Global Expert in Biosimilars
    Head of Biosciences Biosimilars
    Boehringer Ingelheim GmbH
    Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE
    University Of Portsmouth
    Senior Director, European Oncology Biologics Lead
    Mylan Technologies Inc
    Vice President Regulatory Affairs
    Lupin (Europe) Ltd
    Owner and Director
    Impact Medical Education
    General Manager
    Challand Biosimilar Consulting
    Senior Scientist
    MedImmune
    Managing Director
    Cinfa Biotech
    Head of Clinical Safety & Pharmacovigilance
    Fresenius-Kabi
    Senior Commercial Lead - Biosimilars
    Mundipharma International

    Sponsors and Exhibitors

    Official Media Partner

    Supporters

    Biosimilars & Biobetters 2018 Attendee List

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    Biosimilars & Biobetters 2018 PROGRAMME UPDATED

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    Updated Biosimilars & Biobetters 2018 BROCHURE

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    Speaker Interview PHILIPPE BASTIDE, Mundipharma

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    Biosimilars & Biobetters Speaker Interview MICHEL MIKHAIL

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    Biosimilars & Biobetters 2018 PAST ATTENDEES

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    Speaker interview with Niklas Czeloth, Boehringer Ingelheim

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    Speaker interview with Erin Federman

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    Chairman's Invite Letter to Biosimilars & Biobetters Conference 2018

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    2017 Speaker Presentation Teva Pharmaceuticals Europe

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    2017 Speaker Presentation Gedeon Richter

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    Biosimilars & Biobetters 2018 WORKSHOPS

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    Biosimilars & Biobetters 2018 SPEAKERS

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    Sponsors and Exhibitors


    Impact Medical Education

    Sponsors and Exhibitors
    http://www.impactmedicaleducation.com

    Impact helps build global biosimilar brands. Our programs accelerate biosimilar uptake and provide you with meaningful differentiation in an increasingly competitive market. We understand the challenges facing new biosimilars and can advise you on how to maximize clinician engagement and long-term adoption of your brand.

    Media Partners


    Samedan

    Official Media Partner
    http://www.samedanltd.com/magazine/13.

    International Clinical Trials (ICT) is a quarterly magazine edited by Dr Graham Hughes, and written by specialists at the forefront of clinical research. ICT’s coverage of operational developments ranges from adaptive designs in early phase trials through to post marketing research. ICT’s targeted readership consists of key decision makers across the pharmaceutical and biotech industries, along with contract partners and consultants. The magazine is distributed to pharmaceutical professionals in Europe and North America, and is accessed globally online. Read the latest issues, explore the ICT archive and subscribe at www.samedanltd.com/magazine/13.


    GaBI

    Official Media Partner
    http://www.gabionline.net

    Generics and Biosimilars Initiative (GaBI) was founded in 2008. GaBI aims to foster the worldwide efficient use of high quality and safe medicines at an affordable price, thus advancing and supporting the idea of accessible, affordable and sustainable health care. The objective of GaBI is to raise the scientific status of generic and biosimilar medicines, via well-documented and up-to-date information about generic and biosimilar medicines both in print (www.gabi-journal.net) and electronically (www.gabionline.net) in an open access format, providing high quality, scientifically sound and reliable information to healthcare professionals including physicians, pharmacists and nurses, consumers, drug developers, third-party payers, legislators and assessors; who are in need of a reliable, critical and independent source of information on all aspects of generic and biosimilar medicines. Subscribe to gain easy access of information on the latest scientific research and developments in generic and biosimilar medicines via GaBI Online to editorial@gabionline.net; or submit a manuscript to GaBI Journal to editorial@gabi-journal.net. GaBI’s mission – Building trust in cost-effective treatments


    Pharma Journalist

    Official Media Partner
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    The Medicine Maker

    Official Media Partner
    https://themedicinemaker.com/?utm_source=media_partner_24&utm_medium=event&utm_campaign=sae_media_logo

    The Medicine Maker is a print and digital publication as well as a weekly newsletter. At The Medicine Maker, we bring people into the limelight, showcasing the industry’s success stories and examining its biggest points of contention. Engaging content covers the entire spectrum of drug development, keeping all medicine makers up to date with the most pressing topics, trends and technologies driving the pharma industry forward. Register for your FREE print or digital magazine or subscribe to our newsletter here! https://themedicinemaker.com/?utm_source=media_partner_24&utm_medium=event&utm_campaign=sae_media_logo


    Farmavita

    Official Media Partner
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


    The Center of Biosimilars

    Official Media Partner
    https://www.centerforbiosimilars.com

    About Us Health economics experts. Managed care professionals. Key clinical specialists. This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes. We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.


    Biosimilar Development

    Official Media Partner
    http://www.biosimilardevelopment.com/

    Biosimilar Development is dedicated to presenting technical information, thought leadership, and commentary for the biosimilar development and manufacturing community. On this site, users will find exclusive and actionable content on the industry trends and challenges affecting the emerging biosimilars market. Browse our articles, case studies, and white papers on topics related to biosimilar development, manufacturing, quality, distribution, FDA guidance, BPCIA, global markets, government regulations, and intellectual property. Biosimilar Development is part of the Life Science Connect media group, which strives to facilitate connections and foster collaborations in pharmaceutical development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.


    World Pharma News

    Official Media Partner
    http://www.worldpharmanews.com/



    pharmanews hq

    Official Media Partner
    http://http://pharmanewshq.com

    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.

    Media Partners


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    Biocompare

    Supporters
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    Biosave

    Supporters
    http://www.Biosave.com

    Biosave.com brings together the best Life Science promotions, product releases, featured products, publications, videos and events from 100’s of leading Life Science suppliers. Updated 24 hours a day, Biosave is constantly uploading special promotions and exciting product news that you won’t find anywhere else. Our goal is to provide our users with the most exclusive product information to help reach that all important purchasing decision.


    Swiss Biotech Association

    Supporters
    http://www.swissbiotech.org/

    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


    ASD MEDIA

    Supporters
    http://www.asd-network.com

    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
    • Be informed on the latest market developments; www.asd-network.com
    • Find the latest business news; www.asd-network.com
    • Find the upcoming events; www.asd-network.com
    • Find companies and organizations; www.asdsource.com
    • Distribute news globally. www.asdwire.com
    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

    For more detailed information please contact with: ASD MEDIA
    Stefan.koopman@asdmedia.nl


    pharmaphorum

    Supporters
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    Absave

    Supporters
    http://www.absave.com

    Absave.com is the leading savings website for Antibodies and Immunological Products. Search our extensive database of Antibodies, Kits, Proteins & Peptides, Reagents, etc. to find the best savings!


    Technology Networks

    Supporters
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Labsave

    Supporters
    http://www.labsave.com

    Labsave is the leading savings website for Laboratory Equipment and Lab Supplies. We work closely with the top suppliers in the world to bring you the best products at the most competitive prices. We are constantly striving to secure the biggest and most exclusive offers that you won’t find anywhere else! http://www.labsave.com/

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




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